GMP-CapEx Engineering Project Leader

Have you ever dreamed of working for a company that puts people at the heart of its DNA?Are you ready to make a difference?Are you excited about collaborating and sharing your expertise with leaders in our industry?YES? SO ARE WE!GXP CONSULTING Switzerland is a Swiss company made up of a passionate team of life-science professionals. Since 2014, we have been providing our clients with cutting-edge expertise and support covering the entire product life cycle.Join a team where your skills will have a real impact on patients’ lives.We are looking for an experienced Engineering Project Manager to lead the delivery of complex CapEx projects within a GMP-regulated manufacturing environment. You will take ownership of engineering projects from concept and design through execution, qualification, and handover, working closely with EPCM partners, internal engineering teams, manufacturing, quality, and validation.This is an opportunity for an engineering professional who enjoys technical challenges, cross-functional leadership, and delivering tangible results in a highly regulated environment.Your ImpactAs Engineering Project Manager, you will be responsible for the successful delivery of engineering and CapEx projects, ensuring they meet technical, schedule, budget, quality, and GMP requirements.You will:Lead engineering projects end-to-end, from conceptual design and feasibility through execution, qualification, and handover.Define and manage project scope, objectives, deliverables, timelines, resources, and budgets including contract amemdments/claims.Lead and coordinate EPCM partners, contractors, and internal engineering teams, ensuring high-quality and timely delivery.Act as the key engineering interface between Engineering, Manufacturing, QA, Validation, and other stakeholders.Ensure engineering solutions are aligned with customer needsOversee engineering design, procurement, construction, installation, commissioning, and project close-out activities.Drive GMP compliance throughout the project lifecycle, ensuring engineering activities meet applicable regulatory and quality requirements.Manage GMP change control processes, including Technical Change Requests (TCRs) and Change Requests (CRs).Identify and actively manage project risks, technical issues, dependencies, and opportunities.Coordinate with Quality and Validation teams to ensure effective commissioning, qualification, and Performance Qualification (PQ) readiness.Monitor project performance against scope, schedule, cost, quality, and safety objectives.Provide clear project reporting and recommendations to management, enabling timely and effective decisions.Ensure robust technical documentation and a smooth transition from project execution to manufacturing operations.What You Bring :Bachelor’s or Master’s degree in Engineering, Biotechnology, or a related technical discipline.6–8+ years of engineering project management experience, ideally within biopharmaceutical manufacturing or another GMP-regulated industry.Proven experience delivering CapEx projects from concept through execution and qualification and in a range of 500 kCHF up to 8 MCHF.Strong understanding of biopharmaceutical manufacturing processes, GMP requirements, commissioning, qualification, and validation.Experience managing multidisciplinary project teams composed of internal/external resources.Strong technical project management skills, including scope, schedule, budget, risk, and stakeholder management.Excellent communication skills and the ability to work effectively across engineering, manufacturing, quality, and operations.A pragmatic, hands-on approach combined with strong leadership and decision-making capabilities.Proficiency with project management tools such as MS Project, Primavera, or equivalent.Fluency in German and English is required.About us :Human-sized company with great colleagues from a large diversity of cultural and professional backgroundsWe do care about our people, communicate openly and value feedbackWork as a team where every member is valued and appreciatedOpportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.Continuous learning and development opportunities via internal or external training and workshopsCompetitive salary package in line with industry practice together with exceptional employment benefitsAt GXP Consulting Switzerland everyone contributes to our joint success and grows individually!If you also share the same passion and values, we will be glad to hear from you! Please send us your application. #J-18808-Ljbffr